A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA
试验速览
- 阶段
- 4 期
- 入组人数
- 330
- 试验地点
- 13
- 主要终点
- Rate of mother-to-child transmission of HBV
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
详细描述
This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman aged 20 to 35 years old
- •24-26 week of gestation
- •HBsAg positive more than 6 months and HBeAg positive
- •HBV DNA> 200,000 IU/ml
- •Informed consent is signed voluntarily by both husband and wife
- •Good compliance and able to be followed up as planned
排除标准
- •Mothers co-infected with HCV and HIV
- •Evidence of decompensated cirrhosis and liver cancer
- •Mothers had other organ lesions which would affect patient compliance and follow-up plan
- •Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation
- •Mothers received antiviral therapy within 6 months
- •Mothers had history of kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L)
- •Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
- •The infants' biological fathers are infected with HBV
- •Symptoms of threatened abortion during early pregnancy
- •ALT > 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) < 90 ml/min, or Albumin (ALB) < 25 g/L
- •Fetal malformations detected by B-ultrasound during pregnancy
- •Participating in other studies
研究组 & 干预措施
antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF)
All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery.
干预措施: antiviral prophylaxis with Tenofovir Alafenamide Fumarate (Drug)
结局指标
主要结局
Rate of mother-to-child transmission of HBV
时间窗: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up
次要结局
- Rate of birth defect of infants(from enrollment to the last mother delivery, assessed up to 24 months)
研究者
Jinlin Hou
Professor & Director
Nanfang Hospital, Southern Medical University